Impact of Implantation Defects on Intermediate Outcome of Supera Stent for Popliteal Artery Stenosis.

Background: This study reports our experience during the first 50 cases of use of Supera stent for popliteal atherosclerotic lesions treatment.
Methods: This prospective single-arm trial enrolled the first 50 limbs (46 patients) treated in our center with a Supera stent for symptomatic atherosclerotic disease of the popliteal artery and a follow-up longer than 12 months.
Results: Tissue loss (43.5%) was the most common primary indication for intervention, followed by claudication (37.0%) and rest pain (19.5%). Stent implantation was successful in all patients. The majority of lesions were Trans-Atlantic Inter-Society Consensus (TASC) II type D lesions (64%). The lesions treated were localized in P3 zone in 64%, P2 zone in 28%, and P1 zone in 8%. One runoff vessel was the most common situation (42%). Mean follow-up was 16.5 months (range 12-46). The mean preoperative ankle-brachial index increased from 0.38 + 0.37 before intervention to 0.63 + 0.86 postoperatively at 12 months (P = 0.014). Primary patency rates at 3, 6, 9, and 12 months were 95.9%, 91.7%, 89.6%, and 89.6%, and primary assisted patency rates were 95.9%, 93.8%, 93.8%, and 93.8%, respectively. In-stent restenosis was associated with the following: patient <75 years (P = 0.023), female sex (P = 0.032), and TASC-II D lesions (P = 0.041). Implantation defects did not constitute a risk factor for stent restenosis.
Conclusions: The implantation of the interwoven nitinol stents in patients with popliteal occlusive disease is safe and effective, with encouraging patency rates and clinical results after a 12-month follow-up. In our experience, we have not seen significant differences in patency at 1-year follow-up in patients with implantation defects.
(Copyright © 2017 Elsevier Inc. All rights reserved.)